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The Steerable Stylet is intended to allow the physician to define and vary the curvature of the distal end of a compatible pacemaker lead in patients requiring lead implantation for cardiac pacing.

The Steerable Stylet is a sterile, single-use, disposable implantation tool which assists defining and varying the curvature of the distal portion of the pacemaker lead during implantation.

The provided text describes a medical device, the "Steerable Stylet," and its submission for FDA approval (K040001). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through quantitative metrics.

Instead, the document focuses on the regulatory submission process, stating that the device is "substantially equivalent" to a legally marketed predicate device (The Locator Steerable Stylet, Model 4036, K972814). This substantial equivalence is based on "similar performance, technological characteristics, and indication for use." The "Testing" section broadly mentions that "Test results are included in submission" without detailing those results or the defined acceptance criteria.

Therefore, I cannot populate the requested table or answer most of the specific questions as the necessary information is not present in the provided text.

Here's what can be inferred and what is missing:

• Acceptance Criteria and Reported Device Performance: This information is not provided. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting specific quantitative acceptance criteria and the device's performance against them.
• Study Details (Sample Size, Data Provenance, Ground Truth, Training Set): No details are provided regarding any specific studies conducted to establish performance metrics. The submission relies on demonstrating equivalence to a predicate device.
• Adjudication Method: Not applicable as no specific study with ground truth establishment is described.
• MRMC Comparative Effectiveness Study: Not mentioned or implied.
• Standalone Performance Study: Not explicitly described with quantitative results. The "substantial equivalence" claim suggests performance is in line with the predicate, but specific standalone metrics are absent.
• Type of Ground Truth Used: Not applicable, as no study with ground truth established is detailed.
• Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device in the sense that would require a training set.
• How Ground Truth for Training Set was Established: Not applicable.

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